Community Champions
BehavioralThe UNLOAD-Heart Failure Program intervention includes problem solving training, community health worker support, and exercise support from health coaches at YMCAs.
Other names: Multi-level intervention
NCT Number: NCT06364644
This study aims to determine whether a 6-month multilevel intervention involving problem-solving training, exercise training and support from community health workers is more effective in improving outcomes for individuals with low socioeconomic status, type 2 diabetes, obesity, and early cardiac dysfunction than receiving education and access to a community exercise facility.
Interested in participating?
Request Info30 year–70 year
All sexes
Interventional
Not applicable
Johns Hopkins Center for Health Equity, Baltimore, Maryland, United States
This randomized controlled trial employs a 2:1 allocation ratio. The study aims to include 402 individuals from Baltimore City and Hagerstown, Maryland, characterized by low neighborhood and individual socioeconomic status, type 2 diabetes, obesity, and evidence of subclinical heart dysfunction, without a prior clinical diagnosis of heart failure. The 6-month multi-level intervention consists of three key components:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The UNLOAD-Heart Failure Program intervention includes problem solving training, community health worker support, and exercise support from health coaches at YMCAs.
Other names: Multi-level intervention
Monthly newsletters/videos on diabetes self-management, healthy lifestyle and heart failure prevention will be provided, as well as a membership to the local YMCA.
Other names: Education plus access to community exercise facility
Time frame: Baseline and 6 month follow up
Total distance walked in the 6 minutes walk test in meters
Time frame: Baseline and 6 month follow up
Percent change from baseline in hs-cTnT
Time frame: Baseline and 6 month follow up
Absolute change from baseline in hemoglobin A1c
Time frame: Baseline, 6 month follow up, 12 month follow up
The following Health Problem-Solving Scale (HPSS) subscales will be assessed: Impulsive/Careless Problem Solving (IPS), Avoidant Problem Solving (APS), Negative Transfer (NTR), Negative Motivation/Orientation (NMO). Subscale scores are calculated by summing the scores for each item within the respective subscales. Higher subscale scores indicate more of that problem-solving characteristic. The score range for each subscale is as follows: IPS (0-32), APS (0-28), NTR (0-44), NMO (0-20). Total score range 0-124.
Time frame: Baseline, 6 month follow up, 12 month follow up
The Summary of Diabetes Self-Care Activities Scale (SDSCA) is a tool used to measure diabetes self-care activities. 12-items with 5 sub-scales (diet, exercise, home blood glucose testing, foot care, smoking status). The respondent is asked how many days in the past week the behavior was performed (ranges from 0 to 7); The result is an average score between 0 and 7 with higher score indicating better diabetes self-management behavior.
Time frame: Baseline, 6 month follow up, 12 month follow up
The Diabetes and CVD Knowledge Test comprises 16 items, featuring both multiple-choice and true-or-false questions. This assessment tool gauges individuals' comprehension of diabetes, its impact on health, and optimal strategies for managing the condition. The possible score range is 0-17. A higher score indicates a better understanding of diabetes and cardiovascular disease.
Time frame: Baseline, 6 month follow up, 12 month follow up
The MPAQ is a tool used to estimate the frequency in days (number of times per month) and in time (minutes) someone participated in physical activity (e.g. biking, walking, swimming, etc.). Hours per week for all activities are summed to determine activity hours per week averaged over the past year. A higher sum indicates more physical activity. Values can also be weighted by their estimated metabolic cost and expressed as metabolic equivalent (MET) hours per week. Higher METs are associated with better outcomes.
The MPAQ also assesses inactivity, such as the average number of hours per day spent watching television or being confined to a bed or chair for more than 1 week. A higher average indicates less physical activity.
Time frame: Baseline and 6 month follow-up
Change from baseline in weight (kgs)
Time frame: Baseline and 6 month follow-up
Change from baseline in BMI (Kg/m^2).
Time frame: Baseline and 6 month follow up
Change from baseline in hip and waist circumference (centimeters)
Time frame: Baseline and 6 month follow up
Metabolic Syndrome Severity (MetS) Z score calculates an individual's metabolic syndrome severity score by examining five key markers: waist circumference, blood pressure, triglycerides, HDL, and fasting glucose. Score typically ranges from -5 to 5. Higher scores indicate greater metabolic syndrome severity.
Time frame: Baseline, 6 month follow up,12 month follow up
The Patient Activation Measure is a 13-item survey that will assess an individual's knowledge, skills and confidence to managing one's health and healthcare. The PAM scores is calculated and then transformed to a scale with a range from 0-100. A higher PAM score indicates higher patient activation. The score can also be converted into four activation levels: 1 - not believing activation important, 2 - lack of knowledge and confidence to take action, 3 - beginning to take action, 4 - taking action.
Time frame: Baseline, 6 month follow up,12 month follow up
The PROMIS Global Health 10 survey comprises 10 items designed to evaluate both physical and mental health status. Scores are aggregated separately for physical and mental health, each ranging from 4 - 20. Higher scores in both categories indicate better outcomes.
Time frame: Baseline and 6 month follow up
changes in blood pressure from baseline
Time frame: Baseline and 6 month follow up
Percent change from baseline in gal-3
Time frame: Baseline and 6 month follow up
Percent change from baseline in NT-proBNP
Time frame: Baseline and 6 month follow up
Changes in post-walk Borg dyspnea scale which ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"); higher score worse breathing difficulty. Measured in a subset of the population.
Time frame: Baseline and 6 month follow up
Change in peak oxygen uptake (VO2 peak) as assessed by a cardiopulmonary fitness test in a subset of the population.
Contact information is provided by the study sponsor or research team.
Chiadi Ndumele, MD, PhD
CONTACT
Perri Carroll, MPH
CONTACT
Johns Hopkins University
Other
Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure (UNLOAD-Heart Failure)
Acronym: UNLOAD-HF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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